Business Directories

Drug regulators face challenge of ‘biosimilars’

Dubai, April 20, 2008

Middle East drug regulators face a new challenge in dealing with a wave of "biosimilar" versions of established therapies.

Some of the world's biggest-selling pharmaceuticals were developed in the first phase of the biotechnology revolution in the 1980s. But many are now losing their patent protection opening up the market to cheaper, follow-on biotechnology, or biosimilar, drugs, say the organisers of the region's most comprehensive pharmaceutical and biotechnology exhibition and conference taking place in Dubai this month.

So far patents have run out on just a handful of the over 200 biotechnology drugs used to treat around 325 million patients worldwide with cancers, HIV/AIDS, neurological disorders, heart disease, diabetes and rare genetic diseases. The number will increase significantly in the next few years, however.

“Ambiguities over naming, differences in prescribing practices and rules on drug substitution will need to be resolved by drug regulators in the Middle East to ensure safe use of biosimilars”, said Simon Page, Group Director of Life Sciences at IIR Middle East, organisers of the Pharmaceutical and Biotechnology Middle East (PABME) exhibition and conference from 27 to 29 April 2008 at the Dubai International Exhibition Centre.

"The problem is not unique to the region," he said. "Regulators in most parts of the world are wary about approving generic versions of biotech drugs because of their complexity. However, Europe has been more advanced in giving the green light to biosimilars than the United States. European officials have already given approval to biosimilar forms of an anaemia drug and human growth hormone.

"The pressure is mounting from pharmacy managers, insurers and consumer groups who want to see lower drug costs, supported by the generic drug and biotechnology companies."

Biosimilar drugs represent a major market opportunity, as prices are expected to be 25 per cent to 40pc below those of original brands. The price of conventional generic drugs could also quickly fall to a 90pc discount to the original.

India and China, both with major biopharmaceutical sectors, have fast growing generic and biosimilar industries and are staging a major presence at PABME. China in particular is mounting the largest pavilion at the show.

Biosimilars will come under the spotlight in a special presentation on Biotechnology: the Future of Medicine at a conference at PABME by Tom Bols, Director of Government Affairs Europe for Amgen International, the world's biggest biotechnology company.

With advances in life sciences and biotechnology continuing at a hectic rate, the debate about the ethics of the industry is gathering pace.

The conference, called Current Affairs in Pharmaceuticals and Biotechnology, will be held from April 27-29 April.

It will also be examining ethical, religious and cultural issues raised by the use of biotechnology. In addition, current trends in molecular biotechnology; genetics and personalised medicine; development of clinical trials; future aspects of in-vitro fertilisation; and issues and trends in oncology pharmacy will be discussed.

The Middle East's pharmaceutical market is estimated to be worth more than $12 billion and more than 100 companies from over 25 countries in the Middle East, Asia, Europe, the Americas, Africa and Australasia will be exhibiting at PABME.

Dubiotech, the Middle East's first dedicated life sciences hub which will cover 30 million square feet upon completion, is a leading sponsor of PABME 2008 which is supported by the Ministry of H